Development Responsibilities. As between the Parties, Lumena shall have sole authority and responsibility for conducting or having conducted Development activities with respect to Compounds and Licensed Products in the Territory, at its sole cost and expense, in accordance with the terms and conditions of this Agreement. Lumena shall conduct all such activities in compliance in all material respects with all applicable Laws. Lumena shall have sole responsibility and control with respect to seeking Regulatory Approvals to Commercialize the Licensed Products. As between the Parties, Lumena shall hold legal title to all Regulatory Materials within the Territory. Promptly following the Effective Date, Sanofi shall take and cause to be taken such actions and execute such documents that are requested in writing by Lumena to the extent necessary to transfer to Lumena all Regulatory Materials within the Sanofi Know-How.
Appears in 3 contracts
Sources: License Agreement (Mirum Pharmaceuticals, Inc.), License Agreement (Mirum Pharmaceuticals, Inc.), License Agreement (Lumena Pharmaceuticals, Inc.)